Candida VulvovaginitisPhase 3NCT03734991
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
A Phase 3 study testing Ibrexafungerp in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 25 sites in United States.
Trial summary
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Candida Vulvovaginitis
- What is being tested?
- Ibrexafungerp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 25 sitesUnited States
- Study dates
- 4 Jan 2019to 4 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a postmenarchal female subject 12 years and older
- Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Who cannot join
- Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
- Subject is actively menstruating at the time of the Baseline visit.
- Subject has uncontrolled diabetes mellitus.
- Subject has a vaginal sample with pH >4.5.
- Subject has a history of or an active cervical/vaginal cancer.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical Research South
Charleston, South Carolina, 29414
Women's Medical Research Group
Clearwater, Florida, 33759
Clinical Trials Management LLC
Covington, Louisiana, 70006
Wayne State University
Detroit, Michigan, 48201
GYN Center for Women PA
Durham, North Carolina, 27612
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
Unified Women's Clinical Research Greensboro
Greensboro, North Carolina, 27408
Unified Women's Clinical Research- Hagerstown
Hagerstown, Maryland, 21740
TMC Life Research Inc
Houston, Texas, 77054
Altus Research
Lake Worth, Florida, 33461
Center For Women's Health and Wellness LLC - Interspond - PPDS
Lawrenceville, New Jersey, 08648
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
OBGYN Assoc of Mid Florida
Leesburg, Florida, 34748
Medical Research Center of Memphis
Memphis, Tennessee, 38120
Clinical Trials Management LLC
Metairie, Louisiana, 70006
New Age Medical Research Corporation
Miami, Florida, 33186
Unified Women's Clinical Research
Morehead City, North Carolina, 28557
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina, 29572
Group For Women
Norfolk, Virginia, 23502
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607
Womens' Health Care Research Corp
San Diego, California, 92111
Consultants In Women's Healthcare, Inc.
St Louis, Missouri, 63131
Unified Women's Clinical Research - Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
Read the detailed description
Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:
- Oral ibrexafungerp 300-mg dose BID for 1 day
- Oral ibrexafungerp matching placebo BID for 1 day
Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.
All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.
- Conditions
- Candida Vulvovaginitis
- Being tested
- Ibrexafungerp, Placebo
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrexafungerpDrug
Also called SCY-078
Ibrexafungerp 300 mg BID for 1 day
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | 300 mg orally every 12 hrs for 1 day (2 doses in 1 day) Receives: Drug: Ibrexafungerp |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure (Complete Resolution of Signs and Symptoms)
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Measured: Day 8-14
Secondary outcomes (4)
Mycological Eradication (Negative Culture for Growth of Yeast)
percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit
Measured: Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit
Measured: Day 8-14
Complete Clinical Response at Follow-Up
percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit
Measured: Day 25
Overall Treatment-Emergent Adverse Events (Safety Set)
Number of subjects with treatment related adverse events
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start4 Jan 2019
- Primary completion21 Aug 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Candida VulvovaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo-controlled, double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Angulo, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734991
- Sponsor's protocol ID
- SCY-078-303
- Status last verified
- Aug 2021
- First submitted
- 30 Oct 2018
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walley AH, Dupuis LN, Woodahl EL, Killam SR. Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science. Clin Transl Sci. 2025 Sep;18(9):e70362. doi: 10.1111/cts.70362.
PubMed 40970688Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
PubMed 36255448
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT03734991
- Acronym / sponsor ID
- SCY-078-303
- Conditions
- Candida Vulvovaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
Detailed description
Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:
- Oral ibrexafungerp 300-mg dose BID for 1 day
- Oral ibrexafungerp matching placebo BID for 1 day
Subjects will receive their first dose of study drug at the site and will be dispensed the second dose for self-administration at home 12 hours after the first dose. Study Blinding, Randomization and Stratification: This is a randomized, double-blind study.
All site and sponsor personnel will be blinded to treatment assignment. Approximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. For the purpose of maintaining treatment blinding, all subjects randomized to the placebo group will receive matching ibrexafungerp placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Ibrexafungerp (SCY-078) | Experimental | Drug: Ibrexafungerp300 mg orally every 12 hrs for 1 day (2 doses in 1 day) |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is a postmenarchal female subject 12 years and older
- Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Key exclusion criteria (6 listed)
- Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
- Subject is actively menstruating at the time of the Baseline visit.
- Subject has uncontrolled diabetes mellitus.
- Subject has a vaginal sample with pH >4.5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrexafungerpAlso: SCY-078Ibrexafungerp 300 mg BID for 1 day | Drug | Ibrexafungerp (SCY-078) |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Clinical Cure (Complete Resolution of Signs and Symptoms)
Time frame: Day 8-14
measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
4 secondary outcomes
Mycological Eradication (Negative Culture for Growth of Yeast)
Time frame: Day 8-14
Clinical Cure and Mycological Eradication (Responder Outcome)
Time frame: Day 8-14
Complete Clinical Response at Follow-Up
Time frame: Day 25
Overall Treatment-Emergent Adverse Events (Safety Set)
Time frame: Up to 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40970688Walley AH, Dupuis LN, Woodahl EL, Killam SR. Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science. Clin Transl Sci. 2025 Sep;18(9):e70362. doi: 10.1111/cts.70362.
- Derived from this study: PubMed 36255448Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Angulo, MD study director
Scynexis, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibrexafungerp in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (Complete Resolution of Signs and Symptoms) (time frame: Day 8-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734991, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.